Head of Biostatistics & Statistical Strategy

Ocugen; Malvern (Chester County); On-site; USD 300,000 - 460,000; Full time

Job summary

Ocugen in Malvern, PA seeks a Senior Director, Head of Biostatistics to lead statistical strategy and outputs across clinical development programs, ensuring regulatory-ready insights. This role elevates Biostatistics as a core decision‑making engine and aligns statistics with regulatory expectations for gene therapy and rare disease programs.

The Head of Biostatistics will own study design, endpoints, interim analyses, and the preparation of CDISC datasets and integrated summaries, partnering

Qualifications

• Ph.D. or M.S. in Biostatistics, Statistics, or related field required.
• 12+ years of biometrics experience in clinical development.
• Experience leading statistical strategy through regulatory submissions (IND, BLA/NDA).
• Deep experience in rare disease or gene therapy preferred.
• Experience in lean outsourced models with high vendor accountability.

Responsibilities

• Own and define the statistical strategy across all programs, ensuring alignment with clinical, regulatory, and corporate objectives.
• Lead the Biostatistics function and interface with Data Management, Programming, Clinical, and Regulatory.
• Lead regulatory interactions including FDA/EMA meetings and submission strategy.
• Ensure all statistical components of INDs, BLAs, and regulatory responses are defensible, consistent, and inspection-ready.
• Deliver SAPs, TLFs, CDISC-compliant datasets, and integrated summaries.
• Act as core member of program leadership and drive CRO/vendor performance.
• Translate complex statistical outputs into executive-level insights.

Skills

Leadership

Strategic thinking

Regulatory collaboration

Executive communication

Education

Ph.D. or M.S. in Biostatistics, Statistics, or related field

Job description

Ocugen in Malvern, PA seeks a Senior Director, Head of Biostatistics to lead statistical strategy and outputs across clinical development programs, ensuring regulatory-ready insights. This role elevates Biostatistics as a core decision‑making engine and aligns statistics with regulatory expectations for gene therapy and rare disease programs.

The Head of Biostatistics will own study design, endpoints, interim analyses, and the preparation of CDISC datasets and integrated summaries, partnering